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AstraZeneca, Merck Provided Update on US Regulatory Priority Review of Lynparza in Combination With Abiraterone in Metastatic Castration-resistant Prostate Cancer

AstraZeneca and MSD today announced that the US Food and Drug Administration (FDA) has informed AstraZeneca that it will extend the Prescription Drug User Fee Act (PDUFA) date by three months to provide further time for a full review of the supplementary new drug application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of metastati

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AstraZeneca Announced Datopotamab Deruxtecan Showed Encouraging and Durable Efficacy in Patients With Heavily Pretreated HR-positive, HER2-Low or Negative Metastatic Breast Cancer

First results for AstraZeneca and Daiichi Sankyo's TROP2-directed ADC in this setting reported from TROPION-PanTumor01 Phase I trial. Pivotal TROPION-Breast01 Phase III trial is ongoing, evaluating datopotamab deruxtecan in these patients in earlier lines of treatment.

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